Two stakeholders suggest changes to an FDA draft guidance on protocol deviations in clinical studies.
The ethics form submitted to HHS by FDA commissioner nominee Martin Makary says he will resign his position at Johns Hopkins University upon confirmat...
FDA warns Pleasantville, IA-based Chem-Tech about CGMP violations in its manufacturing of finished drugs.
FDA accepts for priority review a Capricor Therapeutics BLA for deramiocel, a cell therapy for treating patients diagnosed with Duchenne muscular dyst...
FDA approves a Celltrion BLA for Stoboclo (denosumab-bmwo), a biosimilar to Amgens Prolia, and Osenvelt (denosumab-bmwo), a biosimilar to Amgens Xgeva...
Wired reports that several FDA-regulated companies have informed the Securities and Exchange Commission that their business could be adversely affecte...
Elon Musks Department of Government Efficiency (DOGE) terminates the leases of 30 FDA field offices and laboratories throughout the U.S.
FDA clears a Damae Medical 510(k) for its deepLive, an artificial intelligence-based imaging tool that provides real-time, three-dimensional visualiza...